Protection of Human Rights in Research Christodoulou Thekla and - - PowerPoint PPT Presentation

Protection of Human Rights in Research

Christodoulou Thekla and Hising Joakim Bioethics 24/10/2016

Overview

 What do we mean by ”protection” and what do we protect?  Historical background  Ethical conflicts within known cases  Discussion points

Protection?

Protection?

• Health
• Scientific design
• Integrity
• Law
• Research
• Susceptibility

Chart flow for History of events:

1939-1945

• Nazi Medical War Crimes: During the Nazi era, experiments were performed
• n non-consenting subjects.

1946

• Nuremberg Doctors’ Trial: The individuals who conducted Nazi experiments

during WWII were tried separately from other war criminals because of their professional status as physicians and the horrendous and unique nature of their crimes. They were found guilty of “crimes against humanity”. 1947

• Nuremberg code: Nazis physicians are tried at Nuremberg, Germany, for

research atrocities performed on Prisoners of war. This resulted in the Nuremberg Code, the first internationally recognized code of research ethics, issued by the Nazi War Crimes Tribunal.

Nazi Medical War Crimes (1939-1945)

• German physicians adopting a “Euthanasia” program: victims deemed of “unworthy of life”
• “Medical experiments” performed on thousands of concentration camp prisoners without informant consent
• Included deadly studies and tortures, e.g. injecting people with gasoline and live viruses, immersing people in ice water,

forcing people to ingest poisons

• As a result, many dead or permanently crippled victims

A victim of a Nazi medical experiment is immersed in icy water at the Dachau concentration camp. SS doctor Sigmund Rascher

• versees

the experiment. Germany, 1942. Nazi physician Carl Clauberg (at left), who performed medical experiments on prisoners in Block 10 of the Auschwitz

• camp. Poland, between 1941 and 1944.

Unethical and gruesome experiments

Survival of Axis alliance military personnel:

• high altitude

experiments

• freezing experiments

Development and testing of pharmaceuticals for German military/soldiers in the field:

• immunization

experiments

• bone-grafting

experiments

• gas experiments

Advance racial and ideological beliefs of the Nazi worldview:

• serological experiments
• sterilization

experiments

Nuremberg code (1947): First modern ethical code

• Set of research ethics principles for human experimentation
• Ethical standard of medical behavior accepted worldwide and established at the Nuremberg trials
• Consequence of Nazi crimes of violating human rights during World War II

Free power of choice and sufficient knowledge of the research

• bjectives

Voluntary informed consent Likelihood of some good resulting Scientific Studies Animal model experimentation Based on prior research Unnecessary injury and suffering Avoidance of physical or psychological harm Humanitarian importance above anything else Benefits should

• utweigh risks

Proper experience of researcher Qualified investigators Freedom of liberty Right to withdraw consent Research must stop if harm is resulting Termination of studies

Newspaper of The New York Times, October 19, 1945, indicating the beginning of Nuremberg trials

Did things get better after the Nuremberg Trials?

Chart flow for History of events:

1932- 1972

• Syphilis Study at Tuskegee: Long-term study of the effects of untreated Syphilis.

1944- 1974

• Cold War Human Radiation Experiments, US: More than 400 experiments to

determine the effects of exposure to ionizing radiation on human health or to calibrate instruments designed to detect radiation. 1946- 1956

• Fernald

state school, Massachusetts: 19 boys who thought they were participating in a science club were fed radioactive milk by researchers who wanted to learn about the digestive system. 1963

• Jewish Chronic Disease Hospital Study: Studies to develop information about the

human immune system’s response to cancer.

Jewish Chronic Disease Hospital study (1963)

• Studies to develop information on the nature of the human transplant rejection

process

• Involved injection of live cancer cells into patients who were hospitalized with

various chronic diseases

• Researchers stated that consent was given orally, but not documented:
• Documentation was not necessary
• More dangerous medical procedures are undertaken without the use of consent

forms

• Would scare the patients unreasonably
• Good cause of action
• True nature of study: Deceiving and unprofessional conduct from the researchers

Chart flow for History of events:

1964

• Declaration of Helsinki: The World

Medical Association drafted the first international agreement recommending ethical standards for clinical research.

The Belmont report (1979)

• Ethical principles and guidelines for the protection of human subjects in research
• Consequence of previous human subject violations
• Practice:

Outcome: Reasonable expectation of success

• Research:

Outcome: Permits a conclusion to be drawn

(A) Defined boundaries between research and practice

• Respect for Persons:
• Having the right to self-govern (autonomy)
• Informed consent
• Beneficence:
• Benefits outweigh the risks
• Justice:
• Equitable selection of participants
• Fairness in distributing benefits

(B) Consists of 3 basic principles

• Serve to preserve the public trust in research
• Protection of human exploitation
• Special protection for most vulnerable (e.g.

children, pregnant women, prisoners)

(C) Overall emphasis of the principles

Puffenberger et al 2004

Puffenberger et al 2004

Cases for discussion

A) Case poly-pharmaca: A medical doctor has observed good treatment effect in two different drugs and wants to try giving both drugs simultaneously to a group of his patients. However, there is a problem; the two drugs have never been combined before. Do you think the doctor should be allowed to give the drug combination to his patients? B) Modern case: Berlin patient Timothy Ray Brown, long known only as the "Berlin Patient" had HIV for 12 years before he became the first person in the world to be cured of the infection following a stem cell transplant in 2007.